Addressing the quality challenge of a human biospecimen biobank through the creation of a quality management system

The objective of the COMET (COllection of MEtabolic Tissues) biobank project is to create a high-quality collection of insulin-sensitive tissues (liver, muscle, adipose tissues, and epiploic artery) and blood sample derivatives (plasma, serum, DNA and RNA), collected from 270 grade 2-3 obese patient...

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Bibliographic Details
Published in:PloS one 2022-12, Vol.17 (12), p.e0278780-e0278780
Main Authors: Servais, Marie-Dominique, Galtier, Florence, Nouvel, Agathe, Rebuffat, Sandra, Laget, Jonas, Géan, Anne, Provost, Nicolas, Lorcy, Frédéric, Rigau, Valérie, Couderc, Guilhem, Géraud, Philippe, Nocca, David, Builles, Nicolas, De Préville, Nathalie, Lajoix, Anne-Dominique
Format: Article
Language:English
Subjects:
Adipose tissue
Adipose tissues
Biobanks
Biological products
Biological Specimen Banks
Biology and Life Sciences
Biomedical research
Body mass index
Centrifugation
Clinical trials
Consent
Deoxyribonucleic acid
Diabetes
DNA
Evaluation
Exploitation
Gastrointestinal surgery
Humans
Insulin
Insulin resistance
Integrity
ISO standards
Life Sciences
Liver
Medicine and Health Sciences
Metabolism
Muscles
Obesity
Patients
Preservation, Biological
Purity
Quality assurance
Quality control
Quality management
Reliability
Reproducibility of Results
Research and Analysis Methods
Ribonucleic acid
RNA
Scientific equipment and supplies industry
Serology
Shelf life
Specimen Handling - methods
Surgery
Tissue banks
Type 2 diabetes
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Summary:The objective of the COMET (COllection of MEtabolic Tissues) biobank project is to create a high-quality collection of insulin-sensitive tissues (liver, muscle, adipose tissues, and epiploic artery) and blood sample derivatives (plasma, serum, DNA and RNA), collected from 270 grade 2-3 obese patients undergoing bariatric surgery. Relevant data on patient such as clinical/biological characteristics and sample handling are also collected. For this, our aim was to establish a Quality Management System (QMS) to meet the reliability and quality requirements necessary for its scientific exploitation. The COMET QMS includes: (1) Quality Assurance to standardize all stages of the biobanking process, (2) Quality Controls on samples from the first patients included in order to validate the sample management process and ensure reproducible quality; and 3) "in process" Quality Controls to ensure the reliability of the storage procedures and the stability of the samples over time. For serum and plasma, several corrective actions, such as temperature handling and centrifugation conditions, were made to the protocol and led to improvement of the volume and quality of samples. Regarding DNA, all samples evaluated achieved a satisfactory level of purity and integrity and most of them yielded the required DNA quantity. All frozen tissue samples had RNAs of good purity. RNA quality was confirmed by RIN, achieving values in most cases over 7 and efficient amplification of housekeeping genes by RT-qPCR, with no significant differences among samples from the same tissue type. In the "in process" Quality Controls, DNA, RNA, and histological integrity of tissues showed no differences among samples after different preservation times. Quality Control results have made it possible to validate the entire biobank process and confirm the utility of implementing QMS to guarantee the quality of a biospecimen collection.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0278780